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CompletedNCT05690633Updated May 13, 2026Results posted

Feasibility of Obtaining Pulse Oximetry Readings From the Oropharynx

An interventional study of Pulse oximetry in Surgery and Arterial Catheterization, Peripheral, sponsored by Joseph D. Tobias. Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2026-05-13.

Sponsored by Joseph D. Tobias · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Non-randomized
Sex
All
01

Study summary

This is a prospective study to evaluate the feasibility of obtaining a pulse oximetry ready from the oropharynx with a standard oximeter probe that has been attached to an oral airway or a tongue blade. The study will compare the values from the peripheral pulse oximeter on a finger, toe, foot or hand with the that from the oropharyngeal oximeter. The study will also compare the saturation from an arterial blood gas (ABG) collected as standard of care with that obtained from the oropharyngeal oximeter.

02

Conditions studied

  • Surgery
  • Arterial Catheterization, Peripheral
03

In context

Lead sponsor

Joseph D. Tobias is the lead sponsor of 28 studies on the registry; 4 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 6 (100%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients undergoing a surgical procedure with general anesthesia and requiring an invasive arterial cannula

Exclusion criteria

Exclusion Criteria:

  • Patients in whom an arterial cannula is not indicated for the surgical procedure
  • Patients in whom a peripheral pulse oximeter value cannot be obtained
  • Patients in whom an invasive arterial cannula cannot be placed
  • Patients with any type of intra-oral pathology or injury
  • Patients in whom access to the oropharynx is restricted or not feasible for any clinical reason
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
100 participants (actual)

Study arms

  • Experimental
    Palate

    The use of a pulse oximeter attached to an oral airway that is in contact with the palate in the oropharynx.

    Device: Pulse oximetry

  • Experimental
    Tongue

    The use of a pulse oximeter attached to an oral airway that is in contact with the tongue in the oropharynx.

    Device: Pulse oximetry

Interventions

  • DevicePulse oximetry

    Noninvasive method of measuring the saturation of oxygen in the blood.

06

What researchers measure

Primary outcomes

  1. Oropharyngeal vs Extremity Saturation

    Difference between the average oropharyngeal oxygen saturation and the average extremity oxygen saturation which were recorded every 2 minutes for a total of 30 minutes.

    Time frame: Baseline

  2. ABG PaO2

    The arterial blood gas (ABG) partial pressure of oxygen (PaO2) collected at the same time as the oropharyngeal oxygen saturation (SpO2) recording.

    Time frame: Baseline

  3. Oropharyngeal SpO2

    The oropharyngeal oxygen saturation (SpO2) recorded at the same time as the arterial blood gas (ABG) partial pressure of oxygen (PaO2) collection.

    Time frame: Baseline

07

Results

Posted May 13, 2026

Participant flow

Participant flow — Overall Study
MilestonePalateTongue
Started5050
Completed5050
Not completed00

Outcome measures

PrimaryOropharyngeal vs Extremity Saturation

Difference between the average oropharyngeal oxygen saturation and the average extremity oxygen saturation which were recorded every 2 minutes for a total of 30 minutes.

Time frame:
Baseline
Reported as:
Median · percent of oxygen saturation
Oropharyngeal vs Extremity Saturation
percent of oxygen saturationPalateTongue
Extremity98 (97 to 99)98 (97 to 99)
Oropharyngeal95 (92 to 96)99 (97 to 100)
PrimaryABG PaO2

The arterial blood gas (ABG) partial pressure of oxygen (PaO2) collected at the same time as the oropharyngeal oxygen saturation (SpO2) recording.

Time frame:
Baseline
Reported as:
Median · mmHg
ABG PaO2
mmHgPalateTongue
ABG PaO2167 (135 to 210)237 (170 to 286)
PrimaryOropharyngeal SpO2

The oropharyngeal oxygen saturation (SpO2) recorded at the same time as the arterial blood gas (ABG) partial pressure of oxygen (PaO2) collection.

Time frame:
Baseline
Reported as:
Median · percentage of oxygen saturation
Oropharyngeal SpO2
percentage of oxygen saturationPalateTongue
Oropharyngeal SpO2100 (99.8 to 100)100 (100 to 100)

Adverse events

Collected over Day of surgery. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Palate0/50 (0%)0/50 (0%)0/50 (0%)
Tongue0/50 (0%)0/50 (0%)0/50 (0%)

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)PalateTongueTotal
<=18 years5050100
Between 18 and 65 years000
>=65 years000
Age, Continuous
Age, Continuous(years)PalateTongueTotal
Median12 (8 to 15)14 (12 to 16)13 (9 to 15)
Sex: Female, Male
Sex: Female, Male(Participants)PalateTongueTotal
Female302757
Male202343
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)PalateTongueTotal
Hispanic or Latino101
Not Hispanic or Latino495099
Unknown or Not Reported000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)PalateTongueTotal
American Indian or Alaska Native000
Asian213
Native Hawaiian or Other Pacific Islander000
Black or African American639
White404181
More than one race257
Unknown or Not Reported000
Region of Enrollment
Region of Enrollment(participants)PalateTongueTotal
United States5050100
Height
Height(centimeters)PalateTongueTotal
Median150 (116 to 162)161.5 (144 to 172)155 (133 to 168)
Weight
Weight(kilograms)PalateTongueTotal
Median41 (23 to 61)52 (38 to 68)50 (25 to 66)

3 further baseline measures are reported on the registry.

08

Study locations

1 site
  • Nationwide Children's Hospital
    Columbus, Ohio 43205, United States
09

References and documents

Publications

  • Syed H, Villalobos EE, Kitio SAY, Hall B, Bryant J, Tobias JD. Feasibility of Obtaining Pulse Oximetry Readings From the Oropharynx. Paediatr Anaesth. 2025 Oct;35(10):816-821. doi: 10.1111/pan.70023. Epub 2025 Jul 31. PubMed 40742001 ↗

Study documents

  • Study protocol · Apr 2, 2024
  • Statistical analysis plan · Apr 2, 2024

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 13, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT05690633
Lead sponsor
Joseph D. Tobias
Responsible party
Joseph D. Tobias (Chief, Dept. of Anesthesiology & Pain Medicine, Nationwide Children's Hospital) — Sponsor-investigator
First posted
Jan 19, 2023
Start date
Jan 9, 2024
Primary completion
Jan 27, 2025
Completion
Jan 27, 2025
Results posted
May 13, 2026
Last update
May 13, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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